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NDC 68776-1003-05 WYANDOTTE SANIFECT E3-NA 99468.4 g/100L Details

WYANDOTTE SANIFECT E3-NA 99468.4 g/100L

WYANDOTTE SANIFECT E3-NA is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Alex C. Fergusson, Inc.. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	68776-1003
Product ID	68776-1003_4d0c25ae-46a0-4ab2-96f8-76f94a73411f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	WYANDOTTE SANIFECT E3-NA
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZALKONIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	99468.4
Active Ingredient Units	g/100L
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Alex C. Fergusson, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 68776-1003-05 (68776100305)

Pricing Information	N/A
NDC Package Code	68776-1003-5
Billing NDC	68776100305
Package	12 BOTTLE in 1 CASE (68776-1003-5) / .207 L in 1 BOTTLE
Marketing Start Date	2011-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6da7f6f9-5392-4048-897f-3fcaab51ca82 Details

ACTIVE INGREDIENTS

DRUG FACTS

ACTIVE INGREDIENTS: BENZALKONIUM CHLORIDE 0.1%

PURPOSE SECTION

ANTIMICROBIAL

KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL INGESTION, SEEK MEDICAL ATTENTION OF CONTACT POISON CONTROL CENTER IMMEDIATELY.

INDICATIONS AND USES SECTION

USES

HAND SANITIZER TO HELP REDUCE BACTERIA THAT POTENTIALLY CAN CAUSE DISEASES

HELPS PREVENT CROSS CONTAMINATION BT HAND CONTACT

HELPS PREVENT DRYING AND CHAFFING OF SKIN

RECOMMENDED FOR REPEATED USE

WARNINGS SECTION

WARNINGS: FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IN CASE OF EYE CONTACT, FLUSH EYES WITH WATER.

STOP USE AND ASK A DOCTOR IF IRRITATION OR REDNESS DEVELOPS, OR IF CONDITION PERSISTS FOR MORE THAN 72 HOURS.

DOSAGE AND ADMINISTRATION SECTION

DIRECTIONS: PUMP A SMALL AMOUNT OF FOAM INTO PALM OF HAND. RUB THOROUGHLY OVER ALL SURFACES OF BOTH HANDS. RUB HANDS TOGETHER BRISKLY UNTIL DRY.

OTHER INFORMATION: FOR FOOD PROCESSING, FOOD SERVICE AND PROFESSIONAL USE ONLY

INACTIVE INGREDIENT SECTION

WATER, CETRIMONIUM CHLORIDE, LAURTRIMONIUM CHLORIDE, DIHYDROXYETHYL COCAMINE OXIDE, GLYCERETH-17 COCOATE

QUESTIONS OR COMMENTS

QUESTIONS OR COMMENTS: FOR PRODUCT OR TECHNICAL INFORMATION, CONTACT AFCO MONDAY TO FRIDAY 8 AM TO 4 PM EST AT 1-800-345-1329 OR VISIT OUR WEBSITE AT WWW.AFCOCARE.COM

PACKAGE LABEL

WYANDOTTE #5581

SANIFECT E3-NA HAND SANITIZER

NDC# 68776-1003-2 CONTENTS: 4 X 1 GALLON

BATCH NO:

EXP DATE:

CONTENTS:

MANUFACTURED BY:

ALEX C. FERGUSSON

800 DEVELOPMENT AVENUE

CHAMBERSBURG, PA. 17201

TOLL FREE: 800 345-1329

CHEMTREC EMERGENCY 800-424-9300

(CHEMTREC CUSTOMER NUMBER: CCN837)

HMIS HAZARD RATING

HEALTH 1

FLAMMABILITY 0

REACTIVITY 0

PERSONAL PROTECTION -

ALEX C. FERGUSSON

800 DEVELOPMENT AVENUE

CHAMBERSBURG, PA. 17201

TEL: 1-800-345-1329

res

12 X 7 oz. bottle Case-Label

res

INGREDIENTS AND APPEARANCE

WYANDOTTE SANIFECT E3-NA

benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68776-1003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	99468.4 g in 100 L

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)
GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68776-1003-2	3.784 L in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2011
2	NDC:68776-1003-5	12 in 1 CASE	01/01/2011
2		0.207 L in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/01/2011

Labeler - Alex C. Fergusson, Inc. (604091413)

Registrant - Alex C. Fergusson, Inc. (604091413)

Name	Address	ID/FEI	Business Operations
Establishment
Alex C. Fergusson, Inc.		798583154	manufacture(68776-1003)

Revised: 12/2019

Document Id: 4d0c25ae-46a0-4ab2-96f8-76f94a73411f

Set id: 6da7f6f9-5392-4048-897f-3fcaab51ca82

Version: 4

Effective Time: 20191209